Wednesday, 20 January 2016

Post the implementation of GDUFA, in the current year 4 cohort of FY 2016, there has been a very
significant positive change with respect to ANDA review timelines. The initial
screening deficiencies/ information requests or acceptance letters are generally
being issued within 1 month of filing ANDAs. The most important screening
deficiency/information request issued by USFDA is related to eCTD aspects,
which in general is given least importance. RA professionals generally ensure
to meet the requirements of ANDA Filing Checklist, which doesn’t summarize the
eCTD requirements in detail, but gives a link to USFDA website where we get all
the guidelines and eCTD requirements details.

In this post, the below listed eCTD
aspects will be discussed in detail, as they are important for avoiding eCTD
related deficiencies.

PDF Document Properties

Fonts and Font Sizes

Embedding of Non –Standard Fonts

Bookmarks and Hyper Linking

Requirements of Scanned Documents

Leaf Title Naming (for eCTD XML)

PDF
Document Properties

The file name is to be given in
abbreviated form with the use of small letters.”Hyphens (-)” should be used in
place of spaces.”Full Stops (.)”, should not be used.

The
title is generally not given under document properties.

The acceptable PDF Versions are 1.4 to
1.7. Irrespective of the version of Adobe Acrobat, PDF Version should be
anything from 1.4 to 1.7 only.

There should not be any security
passwords for opening the document

“Fast Web View”, should be yes. If “Fast
Web View” option is being displayed as “no” it has to be changed to “Yes” as
per following procedure - go to “File” option in the menu bar of PDF File, go
to “Save As Other”, then “Reduced Size PDF”. Under “Make Compatible with”
option “Acrobat 5.0 and later” or “Acrobat 6.0 and later” should ideally be
selected. Next “Ok” should be selected. Finally, the file in which this
correction is being done, should be replaced (We get a message – “The file
already exists. Replace existing file”. We should select “Yes” option). After
this procedure, we should ensure PDF version is anything from 1.4 to 1.7 only.

For Submissions to USFDA, Pages size
should be 8.50 x 11.00 in.

Under Initial View tab - Navigation tab
should be set to “page only”, if the numbers of pages are less than 5 and there
are no bookmarks. Any PDF file with more than 5 pages should be bookmarked in
which case; navigation tab should be set to “Bookmarks Panel and Page”. Page
Layout and Magnification should be set to “Default”.

The maximum length of the filename
should be 64 characters.

The leaf element path length should not
exceed 230 characters.

Fonts
and Font Sizes

Times New Roman 12-point font, is
recommended and should be preferred for narrative text.

Point sizes 9-10 are recommended for
tables; smaller point sizes should be avoided.

Point Size 10 is recommended for
footnotes.

Embedding
of Non –Standard Fonts

All the non – standard fonts should be embedded.
PDF viewing software, substitutes non-standard fonts if the font used to create
the text is unavailable on the reviewer’s computer.

In some cases, substitution of standard
fonts like Helvetica or Times is done by PDF viewing software.

Font substitution can affect a
document’s appearance and structure, and in some cases it can affect the
information conveyed by a document. Hence, embedding of fonts should be
ensured.

However, embedding of font should be
avoided for labels and electronically signed documents.

Note: There are multiple procedures for “embedding font”. You could Google it and follow. If you are facing any difficulty, I’ll be happy to help out.

Bookmarks
and Hyper Linking

There should be appropriate number of bookmarks
in the document. The number of bookmarks should be neither less nor more.

The number of sub heading trees within
book marks should be limited to 3 or 4.

If there is table of contents in the
document, the bookmarks should exactly match with the table of contents (naming
and number of bookmarks).

The
trick for giving bookmarks using Adobe Acrobat – Go
to the page where bookmark is to be given, select the hand tool and go exactly
to the title where the bookmark is to be given (it is to ensured that, no text
is visible above bookmark title) and select the text, press control + B, the
title automatically appears in the bookmark panel (if there are errors in
bookmark title due to misreading of software, correct it manually), right click
on title and press set destination, finally click on all the bookmarks and
check whether they are going to exact destination.

Hyper linking of texts to the
destination is to be ensured, wherever applicable.

Requirements
of Scanned Documents

It commonly happens that, clarity of
documents is not checked before submitting to the Agency. If we are not able to read a document due
to lack of clarity, we definitely cannot expect the reviewer to read the document.

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